ISO INTERNATIONAL STANDARD 9626 Secondedition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods Tubes d'aiguilles en acier inoxydable pour la fabrication de materiel médical Exigences et méthodes d'essai Reference number IS0 9626:2016(E) ISO @IS02016 IS0 9626:2016(E) COPYRIGHT PROTECTED DOCUMENT IS0 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form writtenpermission.Permission canberequestedfromeitherIsOattheaddressbelow orIso'smemberbodyinthecountryof the requester. ISO copyrightoffice Ch. de Blandonnet 8 · CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org ii @ IS0 2016 - All rights reserved IS0 9626:2016(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references ..1 3 Terms and definitions 4 Materials ..2 5 Requirements .2 5.1 General .2 5.2 Surface finish and visual appearance 2 5.3 Cleanliness .2 5.4 Limits for acidity and alkalinity .2 5.5 Size designation 2 5.6 Dimensions 2 5.7 Sample size 5 5.8 Stiffness .5 5.9 Resistance to breakage 7 5.10 Resistance to corrosion .7 Annex A (normative) Methods for preparation of extracts. ..8 Annex B (normative) Test method for stiffness of tubing ..9 Annex C (normative) Test method for resistance of tubing to breakage ..11 Annex D (normative) Test method for resistance to corrosion ..13 Annex E (informative) Rationale with respect to test method for stiffness of tubing ..14 Bibliography .23 @ IS0 2016 - All rights reserved ii